Respiratory ComplicationsNCT02256384

Evaluation of Respiratory Acoustic Monitor in Children After Surgery

A study testing Respiratory Acoustic Monitor in people with Respiratory Complications and Pediatric, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study will evaluate the performance of measuring respiration rate with the Respiratory Acoustic Monitoring (RAM). Read more about this study

Who is it for?: Ages 2 to 16 years
Conditions the study is for: Respiratory Complications, Pediatric
What is being tested?: Respiratory Acoustic Monitor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 2 sitesUnited States
Study dates: Mar 2015to Aug 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female children 2 to 16 years of age
In-patients or 23 hour short stay patients who had a tonsillectomy with a diagnosis or symptoms of obstructive sleep apnea or who had any surgery and receiving an opioid by patient controlled analgesia for post-operative pain control
Child weighs at least 10 kg on day of surgery

Who cannot join

Patient has skin abnormalities (rash, eczema, etc.) at the planned application sites that would interfere with sensor or electrode applications.
Patient is admitted to the Intensive Care Unit
Patient has tracheostomy
Patient is on non-invasive ventilator support

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
UT Southwestern Medical Center - Dallas
Dallas, Texas, 75235

Other trials in United States

About this study

The study will evaluate the performance of measuring respiration rate with the Respiratory Acoustic Monitoring (RAM).

Read the detailed description

The study seeks to determine the reliability and accuracy of the acoustic respiratory monitoring (RAM) in comparison of clinically completed transthoracic impedance monitoring (TI) and manual counting of respiratory rate in postoperative pediatric patients at risk of adverse respiratory events.

Conditions: Respiratory Complications, Pediatric
Being tested: Respiratory Acoustic Monitor
Keywords: Respiration Rate, Respiratory Acoustic Monitor, postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Respiratory Acoustic MonitorDevice
Examine the reliability and accuracy of the respiratory acoustic monitor.

Study groups in NCT02256384
Study group	Role	What they receive
Respiratory Acoustic Monitoring	Experimental	All participants will wear the respiratory acoustic monitoring device. Receives: Device: Respiratory Acoustic Monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM)
The respiratory acoustic monitor records three vital signs: Respiration rate recorded in breaths per minute, oxygen saturation recorded in percentage, and heart rate recorded in beats per minute.
The reliability and accuracy of the respiratory data collected by the RAM was examined by comparing to data collected clinically by the manual counting of the respiratory rate and by the respiratory rate measure by transthoracic impedance . The accuracy of RAM was examined when a staff member goes and register these measurements that occur simultaneously during the first minute of every 2 hour interval to a maximum of a 24 hour monitoring time.
Measured: Up to 24 hours after surgery

Secondary outcomes (2)

Presence of False Alarms
To evaluate the presence of false alarms, bedside clinical monitoring was done every two hour during 5 to 15 minutes (random sample) recording the respiratory rates and evaluating the presence of alarms. If an alarm was activated during the bedside monitoring, it was verified by the investigator if the respiratory rate provided by the device was consistent with the clinical evaluation. False alarms were considered those alarms that are triggered by the device, but during simultaneous clinical evaluation it was verified that the number of breaths per minute were inaccurate. Therefore, the higher number of false alarms detected by one type of monitoring indicates that the device is less reliable detecting the respiratory rate.
Measured: Up to 24 hours after surgery
Tolerance of the RAM
The tolerance is defined as the ratio of the time the sensor stays in place divided by the total expected time of monitoring, expressed as a percentage. The tolerance to the transthoracic impedance pads was not evaluated during this study considering that this is the standard monitoring and that is usually tolerated during the total expected time of monitoring.
Measured: Up to 24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Aug 2015

First posted3 Oct 2014 (estimated)
Study startMar 2015
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Respiratory ComplicationsStudies of the same condition, open and under way.
More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02256384
Sponsor's protocol ID: 2014-6421
Status last verified: Sep 2020
First submitted: 1 Oct 2014
Last updated: 19 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Patino M, Kalin M, Griffin A, Minhajuddin A, Ding L, Williams T, Ishman S, Mahmoud M, Kurth CD, Szmuk P. Comparison of Postoperative Respiratory Monitoring by Acoustic and Transthoracic Impedance Technologies in Pediatric Patients at Risk of Respiratory Depression. Anesth Analg. 2017 Jun;124(6):1937-1942. doi: 10.1213/ANE.0000000000002062.
PubMed 28448390

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Respiratory Complications trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Respiratory Acoustic Monitor in Children After Surgery
ClinicalTrials.gov ID: NCT02256384
Acronym / sponsor ID: 2014-6421
Conditions: Respiratory Complications, Pediatric
Keywords: Respiration Rate, Respiratory Acoustic Monitor, postoperative
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
Collaborators: Masimo Corporation, Children's Medical Center Dallas, University of Texas Southwestern Medical Center
Study start: Mar 2015 (actual)
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 3 Oct 2014 (estimated)
Results: Posted 19 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will evaluate the performance of measuring respiration rate with the Respiratory Acoustic Monitoring (RAM).

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Respiratory Acoustic Monitoring	Experimental	Device: Respiratory Acoustic MonitorAll participants will wear the respiratory acoustic monitoring device.

Who may qualify

Ages: 2 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Male or female children 2 to 16 years of age
In-patients or 23 hour short stay patients who had a tonsillectomy with a diagnosis or symptoms of obstructive sleep apnea or who had any surgery and receiving an opioid by patient controlled analgesia for post-operative pain control
Child weighs at least 10 kg on day of surgery

Key exclusion criteria (4 listed)

Patient has skin abnormalities (rash, eczema, etc.) at the planned application sites that would interfere with sensor or electrode applications.
Patient is admitted to the Intensive Care Unit
Patient has tracheostomy
Patient is on non-invasive ventilator support

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Respiratory Acoustic MonitorExamine the reliability and accuracy of the respiratory acoustic monitor.	Device	Respiratory Acoustic Monitoring

Primary outcome

Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM)
Time frame: Up to 24 hours after surgery
The respiratory acoustic monitor records three vital signs: Respiration rate recorded in breaths per minute, oxygen saturation recorded in percentage, and heart rate recorded in beats per minute. The reliability and accuracy of the respiratory data collected by the RAM was examined by comparing to data collected clinically by the manual counting of the respiratory rate and by the respiratory rate measure by transthoracic impedance . The accuracy of RAM was examined when a staff member goes and register these measurements that occur simultaneously during the first minute of every 2 hour interval to a maximum of a 24 hour monitoring time.

2 secondary outcomes

Presence of False Alarms
Time frame: Up to 24 hours after surgery
Tolerance of the RAM
Time frame: Up to 24 hours after surgery

Results and safety

Results posted to the registry on 19 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Respiratory Acoustic Monitoring	76	62

Primary outcome: Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM)

Time frame: Up to 24 hours after surgery. Mean (Standard Error). Unit: Breaths per minute

Measure	Respiratory Acoustic Monitoring n = 62	Manual Counting n = 62	Transthoracic Impedance n = 62
Value	19.7 (0.52)	19.6 (0.56)	21.3 (0.77)

Population analysed: 62 children from 2 to 16 years old that required postoperatory admission for continuous respiratory monitoring.The respiratory rate was measured and recorded at the same time every 2 hours from the: (a) RAM monitor, (b) thoracic impedance, and (c) manual count over 1 minute. In addition the presence of alarms was also recorded.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Respiratory Acoustic Monitoring	0 of 62 (0%)	4 of 30 (13.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28448390Patino M, Kalin M, Griffin A, Minhajuddin A, Ding L, Williams T, Ishman S, Mahmoud M, Kurth CD, Szmuk P. Comparison of Postoperative Respiratory Monitoring by Acoustic and Transthoracic Impedance Technologies in Pediatric Patients at Risk of Respiratory Depression. Anesth Analg. 2017 Jun;124(6):1937-1942. doi: 10.1213/ANE.0000000000002062.

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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mario Patino, MD principal investigator

Children's Hospital Medical Center, Cincinnati

Peter Szmuk, MD principal investigator

UT Southwestern Medical Center- Dallas

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Respiratory Acoustic Monitor in people with Respiratory Complications and Pediatric, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM) (time frame: Up to 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02256384, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.